Z-1852-2022 Class II Ongoing

Recalled by Surgical Innovations Ltd — Leeds, N/A

Recall Details

Product Type
Devices
Report Date
October 5, 2022
Initiation Date
January 20, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19

Product Description

Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.

Reason for Recall

Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.

Distribution Pattern

US: MA

Code Information

Part/UDI-DI/Lot: ET1207503/05051986012438/735479, EA10NH/05051986012100/734029